NCT03763682

Brief Summary

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

December 3, 2018

Last Update Submit

June 3, 2025

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Incidence of serious device-related adverse events recorded during the study

    6 months

  • Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

    Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Secondary Outcomes (2)

  • Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)

    6,12, 24, 36 months

  • Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)

    12, 24, 36 months

Other Outcomes (4)

  • Therapy response rate

    6, 12, 24, 36 months

  • Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score

    6, 12, 24, 36 months

  • Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS)

    6, 12, 24, 36 months

  • +1 more other outcomes

Study Arms (1)

Genio(TM) system therapy

EXPERIMENTAL

Genio(TM) bilateral hypoglossal nerve stimulation system

Device: Genio(TM) bilateral hypoglossal nerve stimulation system

Interventions

Genio(TM) bilateral hypoglossal nerve stimulation systemDEVICE

Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation

Genio(TM) system therapy

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman between 21 and 75 years of age
  • Body mass index (BMI) ≤ 32 kg/m2
  • Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
  • Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.

You may not qualify if:

  • Unable or incapable of providing informed written consent
  • Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Westmead Private Hospital

Westmead, New South Wales, 2145, Australia

Location

Wollongong Private Hospital

Wollongong, New South Wales, 2500, Australia

Location

Institute Breathing and Sleep Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Hollywood Hospital

Nedlands, Western Australia, 6005, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective, open-label, 2 groups
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 4, 2018

Study Start

January 10, 2019

Primary Completion

June 28, 2021

Study Completion

June 18, 2024

Last Updated

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)